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New DOJ Policy Restricts FDA Authority to Take Enforcement Action Based on Guidance Documents
BlogTobacco Law Blog

On January 25, 2018, the United States Department of Justice (“DOJ”) announced a new policy that bars DOJ from using its enforcement authority to convert federal agency guidance documents into binding rules. The policy follows a November 16, 2017 memorandum by Attorney General Jeff Sessions indicating that agencies should not establish binding obligations through guidance documents, which can be viewed as an attempt to subvert the notice-and-comment rulemaking process that is required when agencies create rules and regulations. Under the new policy, DOJ’s civil litigators cannot use guidance documents to establish legal violations in civil enforcement actions. “Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking,” Associate Attorney General Rachel Brand said. “Consistent with our duty to uphold the rule of law with fair notice and due process, this policy helps restore the appropriate role of guidance documents and avoids rulemaking by enforcement.”

The new policy is likely to have an impact on the Food and Drug Administration’s tobacco regulatory enforcement authority. The FDA commonly uses guidance documents, and some have argued that this practice undermines the Administrative Procedure Act’s requirement that, in order to establish rules that govern regulated parties’ conduct, the agency must undergo notice-and-comment rulemaking. The new policy makes clear that the FDA will not be permitted to rely on guidance documents to underpin civil enforcement actions.

Of course, this is not to say that FDA guidance is wholly irrelevant. Indeed, FDA guidance documents can be an important tool in understanding the agency’s current views regarding a particular legal requirement, including filling in gaps where laws and regulations are insufficiently specific. And while DOJ’s policy prohibits enforcement action based on guidance documents, it ostensibly would not prohibit agencies from declining to take action based on non-adherence to guidance. The policy apparently would not, for example, bar the FDA from declining to approve a premarket review action where the application fails to adhere to applicable guidance.